Job Description

Vaccine Manufacturing QA Associate Specialist

Position Description:

The basic purpose of this position is review and approve batch records. This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance for the Vaccine Manufacturing areas (Media & Filling). This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.

This position will serve as the Quality role in Reliance quality systems, Deviation Management and Change Controls for the Vaccine manufacturing areas. They will conduct Quality Gemba walks within their departments, assists in brainstorming root cause investigation, and execution of Quality Compliance actions assigned to that area. This team member will also be expected to regularly spend time on the shop floor with their respective departments to learn the processes, evaluate compliance and build relationships of trust with production operators and management.

This position will also share a support role for Seed inventory management as a backup.

Daily Duties & Responsibilities:

• Documentation Review / Approval

• Prepare batch record documentation and performs review for compliance to ensure good documentation practices against established SOPs/standards.

• Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.

• Resolves major issues that are not defined by SOP.

• Assist in updating Quality assurance procedures as needed.

• Holds Quality and reliability as high standards of production and service for own work.

• Follows established QA procedures and understands the impact.

• Change control: Perform review and approval of change control as a Quality Representative and SME for their area.

• Deviations / CAPA: Initiates deviation in Quality electronic system when non-conformance is detected during documentation review; Assesses, classifies, and reviews deviations for their area; Participates and supports with Investigations for determination of root causes and develop / approve CAPA as needed.

• SAP: Performs movement transactions in SAP system of product as needed; Performs material control for any material / products due to deviation and perform batch release after deviation closure; Routinely update Production paperwork in SAP after review of batch records and maintain 2008 tracker for document reviews.

• Work collaboratively with 2008 Release Lead as needed by providing updates for 2008 submission and prioritize batch record reviews based on Planning needs.

• Regulatory: Demonstrates understanding of 9CFR regulations; participate in corporate audits as well as USDA audit inspections and complete obligations as assigned.

Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking, and creativity are necessary attributes for this role.

A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Education Minimum Requirement:

• H.S Diploma with 5 years of relevant experience.

Required Experience and Skills:

• Associate's degree with at least 3 years of relevant experience OR Bachelor’s Degree required, (degree in the sciences preferred)

• Minimum of two years of Quality experience in a regulated industry.

• Strong communication skills both written and verbal.

• Experience with investigations, risk assessment, and regulatory inspections.

• Skilled in technical writing.

• Ability to problem solve and present oneself with confidence.

• Candidates have experience in SAP, Aera and Reliance or similar quality systems.

Preferred Education, Experience and Skills:

• Familiarity and/or experience with vaccine manufacturing and testing.

• Analytical thinking / planning / organizing and excellent attention to detail.

• Strong Microbiology or Biotechnology background.

• Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual.

• Project Management experience.

MSJR

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/20/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.